Belmonte M M, Colle E, DeBelle R, Murthy D Y
Can Med Assoc J. 1971 Jan 23;104(2):133-8.
In 1968-69 certain juvenile diabetics receiving NPH insulin began having pre-breakfast glucosuria and mid-morning hypoglycemic reactions. A mail survey of our clinic population and a study done at the Quebec camp for diabetic children in 1969 revealed that certain lot numbers were associated with poor control and that a change to new lot numbers or alternate insulin preparations resulted in better control. "Suspect" insulin preparations and non-suspect insulins were given to newly diagnosed diabetics, and plasma insulin and glucose levels were measured over a 24-hour period. The data confirmed that the "suspect" insulins were causing early hypoglycemia and failing to control hyperglycemia during the latter hours of the 24-hour period. The lower glucose levels were associated with higher plasma insulin levels. The "suspect" insulins were further found to have elevated levels of free insulin in the supernatant fluid.The requirements for quality control of modified insulin preparations are reviewed and suggestions are offered for their improvement.
1968年至1969年期间，一些接受NPH胰岛素治疗的青少年糖尿病患者开始出现早餐前糖尿和上午中段时间的低血糖反应。对我们诊所患者群体的邮件调查以及1969年在魁北克糖尿病儿童营地进行的一项研究表明，某些批次的胰岛素与控制不佳有关，而改用新的批次号或替代胰岛素制剂可使控制情况更好。将“可疑”胰岛素制剂和非可疑胰岛素给予新诊断的糖尿病患者，并在24小时内测量血浆胰岛素和葡萄糖水平。数据证实，“可疑”胰岛素在24小时的后几个小时内会导致早期低血糖，且无法控制高血糖。较低的葡萄糖水平与较高的血浆胰岛素水平相关。进一步发现，“可疑”胰岛素在上清液中的游离胰岛素水平升高。本文回顾了改良胰岛素制剂的质量控制要求，并提出了改进建议。
